Treatment and Suppression of Hairy Leukoplakia in ARC Patients With Oral Acyclovir (ACV)

NCT ID: NCT00002026

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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To evaluate the efficacy of oral acyclovir for the treatment and suppression of Epstein-Barr virus (EBV) related hairy leukoplakia (HL). To determine the long-term safety of acyclovir in the AIDS-related complex (ARC) patient with HL. To monitor the progression of HIV disease in the HL patient and compare to existing historical control data.

Detailed Description

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Conditions

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Leukoplakia, Hairy HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Acyclovir

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Medication:

Allowed:

* Topical antifungal therapy.

Patient must have:

* Newly diagnosed clinical and histological hairy leukoplakia.
* Positive HIV antibody by licensed ELISA or Western blot.

Exclusion Criteria

Co-existing Condition:

Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.

Concurrent Medication:

Excluded within 2 weeks of study entry:

* Systemic antifungal treatment.
* Excluded within 6 weeks of study entry:
* Immunomodulators.
* Systemic antiviral treatment.

Patients with AIDS or a history of intolerance or allergy to acyclovir are excluded.

Prior Medication:

Excluded within 2 weeks of study entry:

* Systemic antifungal.
* Excluded within 6 weeks of study entry:
* Immunomodulators.
* Systemic antiviral treatment.
* Excluded within 8 weeks of study entry:
* Zidovudine (AZT) or other antiretroviral therapy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glaxo Wellcome

INDUSTRY

Sponsor Role lead

Locations

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Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Herbst JS, Morgan J, Raab-Traub N, Resnick L. Comparison of the efficacy of surgery and acyclovir therapy in oral hairy leukoplakia. J Am Acad Dermatol. 1989 Oct;21(4 Pt 1):753-6. doi: 10.1016/s0190-9622(89)70250-4.

Reference Type BACKGROUND
PMID: 2808791 (View on PubMed)

Other Identifiers

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179

Identifier Type: -

Identifier Source: secondary_id

033A

Identifier Type: -

Identifier Source: org_study_id